Interestingly, Pazdur "requires" the confirmatory study be "substantially under way" already, without any Congressional authority to do so.
I don't believe any small biotech company has been granted accelerated approval by Pazdur w/o a confirmatory trial started. One can argue this is more due to problems with the initial application, but it's a coincidence.
Large pharma usually runs all-in-one trials where there is an interim analysis on the surrogate then the trial (theoretically) continues to the survival (co) primary endpoint.
Interestingly, I'm not sure I can recall any of these all-in-one trials that hit the interim actually continued on. Nexavar and Sutent come to mind as both trials allowed crossover after the interim, thereby negating the survival endpoint. Can anyone else think of one of these all-in-one oncology trials that succeeded on the interm surrogate and continue to survival?
Unless otherwise indicated, this is the personal viewpoint of David
Miller and not necessarily that of Biotech Stock Research, LLC.
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